Mexico Becomes First Country To Grant Regulatory Approval To Sanofi’s Dengue Vaccine

Dec 10, 2015

Agence France-Presse: World’s first dengue fever vaccine cleared by Mexico
“The world’s first dengue vaccine won regulatory approval in Mexico on Wednesday, raising hopes that it could prevent more than 100 deaths there a year and eventually perhaps millions around the world…” (Miselem, 12/9).

BBC News: Mexico to get world’s first dengue fever vaccine
“…French pharmaceutical company Sanofi said it developed the vaccine, Dengvaxia, over the past 20 years…” (12/9).

Bloomberg Business: World’s First Dengue Vaccine Approved After 20 Years of Research
“…Sanofi expects more approvals in ‘upcoming weeks’ for the product, called Dengvaxia, in Latin America and Asia, Olivier Charmeil, who heads the Paris-based company’s vaccines unit, said in a telephone interview…” (Kitamura, 12/9).

Financial Times: Sanofi to launch world’s first vaccine for dengue fever in Mexico
“…Mexico’s approval for Dengvaxia highlights the decision by Sanofi to bypass U.S. and European regulators and take the product directly to countries where dengue is endemic. This represents an unusual strategy for the pharma industry which almost always launches products first in the developed world…” (Ward, 12/9).

International Business Times: Sanofi’s Dengvaxia, World’s First Dengue Vaccine, Approved For Use In Mexico
“… ‘With this decision, Mexico moves ahead of all other countries, including France, to tackle the spread of this virus,’ the drug regulator said, in the statement. ‘This vaccine could potentially prevent more than 8,000 hospitalizations and 104 deaths annually and generate savings of up to 1,100 million pesos a year by the reduction in the costs associated with medical care’…” (Pandey, 12/10).

Mexico News Daily: Dengue vaccine in Mexico early next year
“…Called Dengvaxia, the vaccine has only been approved in Mexico for patients aged nine to 45 who live in areas where the disease is endemic, barring its use for younger children — considered to be more at risk — and tourists…” (12/9).

New York Times: First Dengue Fever Vaccine Approved by Mexico
“…But it is still uncertain how widely the vaccine will be deployed, both in Mexico and other countries, because of limits to its effectiveness and national budgets…” (Pollack, 12/9).

Reuters: Sanofi wins first dengue vaccine market approval in Mexico
“…[Guillaume Leroy, who leads the dengue team at Sanofi Pasteur,] said the vaccine reduced the risk of hospitalization by 80 percent and lowered the possibility of developing the severest, hemorrhagic form of the disease by 93 percent…” (Blamont/Manella, 12/9).

VICE News: Mexico Becomes the First Country to Greenlight a Vaccine for Dengue Fever
“…The Mexican authorities have yet to decide whether to include the vaccine in state-sponsored vaccination programs where people can get the shots for free…” (Gorbea/Janowitz, 12/9).

Wall Street Journal: Mexico Approves Sanofi’s Dengue Vaccine but Pricing Questions Remain
“…Olivier Charmeil, head of Sanofi’s vaccines business, said the company will have filed for approval of the vaccine in 20 of the countries where [dengue] is most widespread by the end of the year, and expected to get additional approvals in coming weeks. He added that Sanofi would file for approval in Europe in 2016, and in the U.S. in 2017. Sanofi has also been in talks with the World Health Organization, a company spokeswoman said…” (Roland/Bisserbe, 12/9).